Chronic anal Fissure. Chronic anal Fissure
Conditions
Interventions
Intervention 1: Topical formulation of Myrtus communis L, three times a day on anus. Intervention 2: Diltiazem, three times a day on anus.
Sponsors
Fasa University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria:the age over 18 years to maximum 70 years;The presence of symptoms of chronic anal fissure (including: bleeding, pain, or both,) for more than 6 weeks;the presence of anal fissure in physical exam;the appearance of horizontal fibers of internal anal sphincter and or sentinel anal tag or hypertrophic papilla;;written informed consent for inclusion.
Exclusion criteria
Exclusion criteria: Exclusion criteria:sensitivity and allergy to Myrtus communis L. or Diltiazem or Acetaminophen ;anal or rectal surgeries during 12 weeks ago;inflammatory bowel disease;others anal disease including abscess,fistula,moderate or severe eczema around anus or mass(pile);Immunodeficiency diseases;A history of diseases that require continued consumption of analgesics;any cardio-vascular or cerebro-vascular disease;consumption of calcium channel blochers drugs in general or current use of them in threatment of fissure;history of radiotherapy to pelvic region;anal fibrosis or fixed stenosis;history of important renal ,liver,neurologic,hematologic and psychiatry diseases;history of stool incontinency;history of chronic constipation or constipation during 4 weeks ago( 2 episodes defication or less weekly with straining or dense stool passing);pregnancy and lactation;alcohol and opium addiction;inability to cooperate in completing forms(mood disorders or language problems)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Discomfort during defication. Timepoint: At the beginning of intervention and every week by phone call. Method of measurement: Visual Analogue Scale.;Anal pain after defication. Timepoint: At the beginning of intervention and every week by phone call. Method of measurement: Visual Analogue Scale.;Anal bleeding. Timepoint: At the beginning of intervention and every week by phone call. Method of measurement: Visual Analogue Scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient's Global Impression of Improvement (PGI-I). Timepoint: At the beginning of intervention and every two weeks in person. Method of measurement: Visual Analogue Scale.;Reepithelialization. Timepoint: At the beginning of intervention and every two weeks in person. Method of measurement: Physical exam.;Comparison of possible complications of topical formulation of Myrtus communis L.with Diltiazem. Timepoint: Every week by phone call. Method of measurement: Question by check list.;Comparison of topical formulation of Myrtus communis L.with Diltiazem at amount of acetaminophen consumption. Timepoint: Every week by phone call. Method of measurement: Based on counting pills. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr.Abdolali Pakdaman
Fasa University of Medical Sciences
Outcome results
None listed